tbuckley/cabot-search huggingface dataset:
The effects of social determinants of health on colorectal cancer screening.
Authors: Isabelle Franklin, Rebecca Gambatese, Theodore R. Levin, Quyen Ngo-Metzger, Gloria D Coronado
Journal: Journal of Clinical Oncology (2023)

6568 Background: Colorectal cancer is the 3 rd leading cause of cancer death in the United States yet has consistently lagged in screening rates compared to other cancers. While patient-reported barriers have been previously described, few studies have analyzed how patients’ social needs affect screening rates. Methods: This cross-sectional study includes 3974 Kaiser Permanente (KP) patients ages 50-75 years who completed the 2020 KP National Social Needs Survey. Survey respondents were from the seven KP regions of Southern California, Northern California, Colorado, Washington, Northwest, Georgia, and Hawaii. Five Social Needs categories were assessed: Financial Strain, Housing Instability, Transportation Issues, Social Isolation, and Food Insecurity. Being up to date on CRC screening was determined from patients’ KP electronic health records, defined as meeting HEDIS criteria for screening. Multivariate analyses compared the level of social need to the respondents’ completion of colorectal screening between the years of 2019-2021, adjusting for age, sex, race/ethnicity, diagnostic category group (DxCG), neighborhood deprivation index (NDI), and insurance type. Results: Among the 3974 survey respondents, 92.2% were up to date on their colorectal cancer screening. Not being up to date on CRC screening was significantly associated with having any social need and having severe needs in four of the five social need domains adjusted for sociodemographic and health status (Table). Patients were less likely to be screened if they had severe financial strain (OR 0.54, 95% CI 0.40-0.73), severe social isolation (OR 0.52, 95%CI 0.38-0.71), severe transportation issues (OR 0.33, 95% CI 0.18-0.61), and severe food insecurity (OR 0.41, 95% CI 0.27-0.62). No significant association between screening status and the domain of severe housing instability were found (OR 0.74, 95% CI 0.52-1.06). Conclusions: Respondents with financial strain, social isolation, food insecurity, and transportation issues had lower odds of being up to date with colorectal cancer screening. Future efforts aimed to improve colorectal cancer screening rates should assess patients’ social needs and target ways to address these potential barriers to screening. [Table: see text]
Patient-reported outcomes (PROs) in primary advanced or recurrent endometrial cancer (pA/rEC) for patients (pts) treated with dostarlimab plus carboplatin/paclitaxel (CP) as compared to CP in the ENGOT-EN6/GOG3031/RUBY trial.
Authors: Mansoor Raza Mirza, Matthew A. Powell, Caroline Lundgren, Vladyslav Sukhin, Bhavana Pothuri, Lucy Gilbert, Sarah Gill, Graziana Ronzino, Nicole Nevadunsky, Stefan Kommoss, Lyndsay Willmott, Ingrid Boere, Cara Amanda Mathews, Joseph Buscema, Michael Teneriello, Mark S. Shahin, Oren Meyers, Jamie Garside, Robert L. Coleman, Brian M. Slomovitz
Journal: Journal of Clinical Oncology (2023)

5504 Background: In RUBY, a phase 3, global, randomized, double-blind, placebo (PBO)-controlled trial, dostarlimab+carboplatin/paclitaxel demonstrated significant and clinically meaningful improvement in PFS compared with PBO+CP in pts with pA/rEC. PROs are reported here. Methods: 494 pts with pA/rEC were randomized 1:1 to dostarlimab (D)+CP or PBO+CP Q3W for 6 cycles followed by D or PBO monotherapy Q6W ≤3 yrs or to disease progression. EORTC QLQ-C30 and EN24 were prespecified secondary endpoints. PROs were administered on Day 1 of each treatment (tx) cycle (C), end of tx (EOT), and at safety and survival follow-ups and reported here for C7, the end of chemotherapy (chemo) and C13, and the end of 1 yr of study. Change (chg) from baseline (BL) to C7/C13 was calculated for all scales assessed. Mixed model for repeated measures analysis was conducted to generate least-squares means (LSM), adjusting for correlations across multiple time point assessments within a pt and controlling for the BL value for the global, pain, fatigue, and physical function (PF) scores. Results: PRO outcomes were similar for D+CP and PBO+CP through the chemo period (C7). The table shows selected scores at C7 and C13 for mean (SD) and chg from BL. Further, no differences across the 3 yr period between the 2 arms were reported; LSM (standard error) for global QoL was 0.5 (1.42; P=0.72), PF was −0.7 (1.39; P=0.63), fatigue was 0.2 (1.75; P=0.91) and pain was −1.0 (1.99; P=0.62). Mean chg from BL to EOT showed improvement in back/pelvic pain for D+CP and deterioration in global QoL/GHS, social functioning, body image, and chg in taste for pts on PBO+CP. Conclusions: Dostarlimab + CP significantly improved PFS while maintaining HRQoL, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796 . [Table: see text]
Influence of modified Lugano criteria by pre-infusion tumor kinetics on early survival prediction for patients with lymphoma under chimeric antigen receptor T-cell therapy.
Authors: Wolfgang G. Kunz, Viktoria Blumenberg, Kai Rejeski, Veit Buecklein, Christian Schmidt, Franziska Dekorsy, Peter Bartenstein, Jens Ricke, Michael von Bergwelt, Marion Subklewe, Michael Winkelmann
Journal: Journal of Clinical Oncology (2023)

e19500 Background: Chimeric antigen receptor T-cell therapy (CART) is effective for patients with refractory or relapsed (r/r) lymphoma with prolongation of survival. We aimed to improve the prediction of Lugano criteria for overall survival (OS) at 30-day follow-up (FU1) by including the pre-infusion tumor growth rate (TGR pre-BL ) and its early change to 30-day FU1 imaging (TGR post-BL ). Methods: Consecutive patients with pre-baseline (pre-BL), baseline (BL) and FU imaging around day 30 with CT or PET/CT before CART were included. TGR was defined as change of Lugano criteria-based tumor burden between pre-BL, BL and FU examinations in relation to days between imaging exams. Overall response and PFS were determined based on Lugano criteria. Proportional Cox regression analysis studied association of TGR with OS. For survival analysis, OS was analyzed using Kaplan-Meier survival curves. Results: 59 out of 81 patients met the inclusion criteria. At 30-day FU 8 patients (16%) had a CR, 25 patients (42%) a PR, 15 patients (25%) a SD, and 11 patients (19%) a PD according to Lugano criteria. The Median TGR pre-BL was -0.6 mm 2 /d, 24.4 mm 2 /d, -5.1 mm 2 /d, and 18.6 mm 2 /d and the median TGR post-BL was -16.7 mm 2 /d, -102.0 mm 2 /d, -19.8 mm 2 /d and 8.5 mm 2 /d in CR, PR, SD, and PD patients, respectively. PD patients could be subclassified into a cohort with an increase in TGR (7 of 11 patients [64%], PD TGR pre-to-post-BL INCR ) and a cohort with a decrease in TGR (4 of 11 patients [36%], PD TGR pre-to-post-BL DECR ) from pre- to post-BL. PD TGR pre-to-post-BL DECR patients exhibited similar OS to patients classified as SD, while PD TGR pre-to-post-BL INCR patients had significantly shorter OS (65 days vs 471 days, p &lt; 0.001). Conclusions: In the context of CART, the additional use of TGR pre-BL and its change to TGR post-BL determined at 30-day FU1 showed better OS prognostication for patients with overall progressive disease according to Lugano criteria. Therefore, this modification of the Lugano classification should be explored as a potential novel imaging biomarker of early response. [Table: see text]
Risk factors for lymph node metastasis and clinical outcomes in cervical cancer patients following primary radical hysterectomy: A single-center analysis of 1495 patients.
Authors: Lili Qian, Weiqi Yin, Xingkun Zhao, Zhen Shen, Jing Zhu, Min Li, Tianjiao Zhang, Ying Zhou
Journal: Journal of Clinical Oncology (2023)

e17525 Background: Histopathological information obtained from surgical specimen is important to identify patients at increased risk for disease relapse and mortality. Lymph node metastasis (LNM) carries the highest impact on decreased survival in suspected early-stage cervical cancer. To further identify risk factors for LNM and prognosis in early stage cervical cancer patients is definitely necessary owing to the findings from different centers are inconsistent. Methods: A total 1495 cervical cancer patients were diagnosed with stage IA2-IIA cervical cancer according to clinical stage and underwent radical hysterectomy between April 2009 and December 2020. The stage of all the patients were reclassified after surgery according to FIGO 2018. We analyzed their clinicopathologic data to identify the risk factors for LNM. Among all the patients, the progression-free survival (PFS) and overall survival (OS) of 1109 patients between 2015 and 2020 were collected and analyzed. Results: The incidence of LNM is 18.8% in all 1495 patients, which increases with depth of cervical stromal invasion, tumor size, lymphovascular space involvement (LVSI) and vaginal wall invasion in univariate analysis. Multivariable analysis shows only stromal invasion (OR, 3.0; 95% CI, 1.7–5.3; P &lt; 0.001) and LVSI (OR, 4.9; 95% CI, 3.6-6.7; P&lt;0.001) are to be independent risk factors for LNM. In addition, the clinical parameters age is a protective factor against LNM in both univariate and multivariable analysis(P&lt;0.001). Among the 1109 patients, the median follow-up time is 49.7 months. Multivariate analyses using the Cox proportional hazards model show that LNM (HR, 8.5; 95% CI, 3.0-23.9; P&lt;0.001), stromal invasion (HR, 3.4; 95% CI, 2.2-5.4;P&lt;0.001) and special histologic type (HR, 3.2; 95% CI, 1.4-7.6; P=0.006) are independent prognostic factors for OS as well as PFS in early stage cervical cancer. Conclusions: The pattern of cervical stromal invasion and presence LVSI, but not the primary tumor size, predict risk of nodal metastasis. Cervical stromal invasion, LNM and special histologic type (non-squamous cell carcinoma; non-Adenocarcinoma) are independent prognostic factors for OS as well as PFS in early stage cervical cancer. [Table: see text]
Updated efficacy and safety data from the AGILE study in patients with newly diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine.
Authors: Stéphane De Botton, Pau Montesinos, Susana Vives Polo, Ewa Zarzycka, Jianxiang Wang, Marta Riva, Michael Heuser, Rodrigo T. Calado, Andre C. Schuh, Su-Peng Yeh, Jianan Hui, Diego A. Gianolio, Prapti Arvind Patel, Christian Recher, Hartmut Dohner
Journal: Journal of Clinical Oncology (2023)

7012 Background: Ivosidenib (IVO) is a potent oral targeted inhibitor of mutant IDH1. In the AGILE study in patients (pts) with newly diagnosed IDH1-mutated acute myeloid leukemia, IVO plus azacitidine (AZA) significantly improved event-free survival (EFS), overall survival (OS), complete remission (CR), and CR or CR with partial hematologic recovery (CR+CRh) rates v placebo (PBO) plus AZA. As of March 2021, median OS (mOS) was 24 months (IVO+AZA) v 7.9 months (PBO+AZA; HR: 0.44; p=0.0005). Long-term follow-up data are presented. Methods: In the double-blind AGILE study, pts were randomized 1:1 to IVO 500 mg QD + AZA 75 mg/m 2 SC or IV for 7 days in 28-day cycles, or PBO+AZA. Long-term follow-up data (June 2022) for OS, blood count recovery, transfusion independence and safety are described here. Results: 148 pts were randomized: 73 to IVO+AZA; 75 to PBO+AZA. Median treatment duration was 10.8 months (IVO+AZA) v 3.2 months (PBO+AZA). Five PBO+AZA pts crossed over to IVO+AZA after March 2021 (Table), and no adjustment was made for crossover in the updated OS analysis. At a median follow-up of 28.6 months, mOS was 29.3 months (95% CI 13.2, not reached) for IVO+AZA v 7.9 months (95% CI 4.1, 11.3) for PBO+AZA (HR 0.42 [0.27, 0.65]; p&lt;0.0001). OS rates were 62.9% and 38.3% at 12 months and 53.1% and 17.4% at 24 months, with IVO+AZA and PBO+AZA, respectively. In the IVO+AZA arm, hemoglobin levels steadily increased from baseline (BL; 88.8 g/L) to cycle 8, and then stabilized; mean platelet count recovered from BL values (72.7 x 10 9 /L) as early as week 8 (171.9 x 10 9 /L) and remained stable; and mean neutrophil counts rapidly increased from BL (0.98 x 10 9 /L) to week 3 (3.99 x 10 9 /L) and week 4 (4.36 x 10 9 /L), and then stabilized to within the normal range. Conversion from BL transfusion dependence (red blood cell and/or platelet transfusion dependence) to post-BL transfusion independence was significantly higher with IVO+AZA than PBO+AZA (53.8% v 17.1%, respectively; p=0.0004). There were fewer neutropenic fever events (27.8% v 33.8%) and infections (34.7% v 51.4%) with IVO+AZA than with PBO+AZA. TEAEs led to discontinuation of IVO+AZA or PBO+AZA in 26.4% and 25.7% of pts, respectively. Conclusions: Updated data on OS (&gt;5 months longer mOS and a greater risk reduction in deaths compared to the initial analysis), transfusion independence, blood count recovery and safety confirms the clinically and statistically robust benefit in favor of IVO+AZA at long-term follow up. Patient disposition. Clinical trial information: NCT03173248 . [Table: see text]
Introducing yttrium-90 radioembolization to atezolizumab and bevacizumab regimen for intermediate and advanced stage hepatocellular carcinoma: A preliminary report of safety and effectiveness.
Authors: Qian Yu, Yating Wang, Ethan Ungchusri, Mikin Patel, Anjana Pillai, Thuong Van Ha, Chih-Yi Liao, Osman Ahmed
Journal: Journal of Clinical Oncology (2023)

e16231 Background: The IMbrave150 Phase III trial demonstrated superiority of atezolizumab and bevacizumab (Atezo/Bev) over sorafenib in unresectable hepatocellular carcinoma (HCC). Combined radiotherapy and immune checkpoint inhibitors have been shown to induce synergistic effects in treatment of HCC and other solid tumors. Barcelona Clinic Liver Cancer 2022 updated guidelines recommend consideration of transarterial radioembolization (TARE) for early stage and very early stage HCC. The present study sims to evaluate the safety and effectiveness of combining TARE and the Atezo/Bev regimen for intermediate and advanced stage HCC. Methods: Retrospective review at a single institution was performed between May 2021 and December 2022. Patients who received TARE using yttrium-90 (Y90) with concomitant or sequential Atezo/Bev systemic treatment were included. The following outcomes were retrieved: overall survival (OS), radiologic tumor response, progression-free survival, technical adverse events related to TARE, and toxicity based on the National Cancer Institute–Common Terminology Criteria for Adverse Events version 5.0. Results: Ten consecutive patients (9 male, 1 female) with unresectable HCC received TARE and Atezo/Bev were included. A total 21 of doses of Y90 were administered with a median target dose of 156 Gy. Tumor control was achieved in all target lesions (100%) based on modified Response Evaluation Criteria in Solid Tumors criteria. Overall disease progression occurred in 4 patients after TARE with a 6- month PFS of 80% (95%CI: 40.9-95.6%) and 12-month PFS of 53.3% (17.3%-79.8%). Two patients died during follow-up, with 6-month and 12-month OS rates of 88.9% (95%CI: 43.3-98.4%) and 76.2% (95%CI: 33.2-93.5%), respectively. One patient developed grade 3 transaminitis and hypoglobulinemia. Atezo/Bev was switched to Lenvatinib in one patient due to myositis. Bevacizumab was held in one patient due to suspected transient ischemic attack. Conclusions: This small patient cohort demonstrated preliminary safety and effectiveness of TARE in combination with Atezo/Bev in treating intermediate and advanced stage HCC. Further prospective and comparative studies with large sample sizes are warranted.
Cascade genetic testing (CGT) female first-degree relatives (FDR) of men with germline <i>BRCA2 </i>mutations (g<i>BRCA2</i>mut) and prostate cancer (PCa): A cost-effectiveness analysis.
Authors: Alexie A Carletti, Aaron B Caughey, Alexandra Sokolova
Journal: Journal of Clinical Oncology (2023)

e17099 Background: g BRCA2mut are associated with increased risk of PCa, breast cancer (BC), and ovarian cancer (OC). ~5% of men with metastatic PCa have g BRCA2mut. CGT is recommended for their relatives as there are implications for cancer prevention and early detection strategies. Little is known about CGT initiated by men with PCa. Here we evaluate the cost-effectiveness of CGT in FDR of men with PCa and g BRCA2mut. Methods: A decision-analytic model was created with TreeAge software to compare BC and OC outcomes for female FDRs who underwent CGT for g BRCA2mut versus no CGT. Our theoretical cohort contained 100,000 females, a conservative estimate of patients who could benefit from CGT. We used literature derived estimates to determine the percentage of patients that would pursue risk-reducing mastectomy, risk-reducing salpingo-oophorectomy, both surgeries, or surveillance after CGT. Outcomes included BC or OC diagnoses, survivorship, and cancer death. We derived all probabilities, costs, utilities, and life expectancies from the literature and discounted quality adjusted life years (QALYs) at a rate of 3%. Incremental cost-effectiveness (ICER) was calculated to determine the cost per QALY gained and set the willingness-to-pay threshold at $100,000/QALY. We assessed the robustness of the model with sensitivity analyses. Results: In our theoretical cohort, CGT of female FDRs resulted in 12,910 less BC diagnoses and 6,360 less BC deaths. CGT was associated with lower BC death rates (26.1%) compared to no CGT (35.8%). OC survival rates were higher with CGT (73.1%) compared to no CGT (36.4%). Our model resulted in lower costs and higher QALYs (a dominant strategy) among the CGT cohort with an ICER of -$7,211.40 per QALY, saving an estimated $595 million. We found that CGT in females was the dominant strategy in 100% of the samples, once uncertainty was incorporated into our model inputs via Monte Carlo simulation. The cost-effectiveness of CGT for male FDRs will be presented at the meeting. Conclusions: In this study, CGT of female FDRs of men with PCa and g BRCA2mut was the dominant strategy to improve BC and OC outcomes, including increased survivorship and reduced BC and OC development. CGT was associated with reduced costs and increased QALYs. CGT for female FDRs of patients with PCa and g BRCA2mut may be a cost-effective approach for identifying and informing individuals with potentially harmful mutations. [Table: see text]
The association between antibiotics administration and outcomes in men with chemotherapy-naive metastatic castration-resistant prostate cancer: Secondary analysis of two randomized clinical trials.
Authors: Xudong Ni, Yu Wei, Ding-Wei Ye, Yao Zhu
Journal: Journal of Clinical Oncology (2023)

e17054 Background: The associations of antibiotics with overall survival (OS) and radiographic progression-free survival (rPFS) in trials in chemotherapy-naive metastatic castration-resistant prostate cancer remain unclear. Methods: COU-AA-302 (NCT00887198, n = 1088) and ACIS (NCT02257736, n = 982) patients were stratified by antibiotics administration. Since there was evidence of a threshold phenomenon, the association of duration of antibiotics administration and OS was assessed using a segmented linear regression model. Kaplan–Meier survival analysis was used to compare OS and rPFS. Hazard ratios were calculated using a multivariable Cox proportional-hazard model. Results: Using segmented linear regression models, we selected ≥30 days as the threshold for antibiotics administration in clinical trials. In COU-AA-302 Abiraterone + Prednisone (AAP) subgroup, antibiotics administration was associated with prolonged OS (50.4 vs. 33.8 months, HR0.57, 95%CI 0.38–0.84, P = 0.004) and prolonged rPFS (27.7 vs. 12.8 months, P = 0.0095). In COU-AA-302 Placebo + Prednisone (PLA) subgroup, antibiotics administration was also associated with prolonged OS (50.4 vs. 29.0 months, HR0.41, 95%CI 0.26–0.63, P &lt; 0.001) and prolonged rPFS (16.46 vs. 5.72 months, P &lt; 0.001). Antibiotics administration also improved patients’ outcomes in ACIS. In ACIS Apalutamide + Abiraterone + Prednisolone (AAAP) subgroup, antibiotics administration was associated with prolonged OS (43.3 vs. 27.3 months, HR0.68, 95%CI 0.54–0.85, P &lt; 0.001) and prolonged rPFS (30.5 vs. 18.2 months, P &lt; 0.001). In ACIS Placebo + Abiraterone + Prednisolone (PAAP) subgroup, antibiotics administration was also associated with prolonged OS (45.4 vs. 30.2 months, HR0.62, 95%CI 0.50–0.78, P &lt; 0.001) and prolonged rPFS (23.4 vs. 13.4 months, P &lt; 0.001). Conclusions: Within the limitations of post-hoc sub-analyses, antibiotics administration is associated with prolonged OS and rPFS in men with chemotherapy-naive metastatic castration-resistant prostate cancer. Further pharmacological researches and prospective clinical trials are needed to increase the indications for these drugs to benefit prostate cancer patients.
Maintenance therapy for patients with recurrent or metastatic cervical cancer: A multicentre, cohort study.
Authors: Chen Peng, Qiufen Guo, Tingting Zhang, Jinlong Chen, Naifu Liu, Peile Yan, Yuanyuan Lu, Anqun Ma, Pengzhong Lv, Jing Liu, Peng Xie
Journal: Journal of Clinical Oncology (2023)

e17518 Background: Maintenance therapy with alternative agents after chemotherapy was shown to improve the overall survival in some advanced cancers such as breast cancer, lung cancer, ovarian cancer and so on. However, maintenance therapy is not accepted as the standard treatment for recurrent/metastatic cervical cancer. Aim of this study is to elucidate the efficacy of maintenance therapy in cervical cancer and to explore the factors associated with the prognosis of recurrent or metastatic cervical cancer. Methods: In this multicenter cohort study, we retrospectively collected patients with a diagnosis of either recurrent or stage IVB cervical cancer to receive first-line chemotherapy with or without maintenance therapy. Patients did not have disease progression with chemotherapy and were divided into maintenance therapy group (Arm A) and conventional chemotherapy group (Arm B). Information on clinical characteristics, metastasis information, treatment outcome and survival of patients was collected using an electronic medical record system. The endpoints of the study were OS and PFS. Data were analyzed for general characteristics and survival using SPSS25.0 software, and the results were considered statistically significant at P &lt; 0.05. Results: Between January 2019 and July 2021, a total of 270 patients were enrolled from 6 institutions in China. 26 patients were excluded because of short treatment cycles (less than 3 cycles). Finally, a total of 66 patients in Arm A and 178 patients in Arm B were analyzed for survival. The addition of maintenance significantly prolonged overall survival. Overall survival at 3 year was 50.1% in Arm A and 27.8% in Arm B (median overall survival, ≥36 months vs. 22 months; P &lt; 0. 001). The median progression-free survival was 21 months in Arm A and 14 months in Arm B (P = 0.025). Univariate survival analysis showed that age, maintenance therapy, combined radiotherapy, and number of extra-pelvic metastases were associated with PFS. Further multifactorial analysis showed that maintenance therapy, combined radiotherapy, and number of extra-pelvic metastases were independent prognostic factors for patients with recurrent or metastatic cervical cancer. Conclusions: The addition of maintenance therapy significantly prolonged overall survival as well as progression-free survival in patients with recurrent or metastatic cervical cancer and did not increase the incidence of serious adverse events. It is time to consider maintenance therapy as the standard treatment after conventional chemotherapy for recurrent or metastatic cervical cancer, rather than waiting for disease progression.